MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. TEGO¿ CONNECTOR; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number D1000

Device Problem Material Split, Cut or Torn (4008)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/20/2023

Event Type  malfunction  

Event Description

The event involved a tego¿ connector where it was reported that while being connected to a patient where the end of the tego cap peeled causing high arterial pressures upon initiation of hemodialysis.Unexpected or prolonged care is unknown and invasive procedure is not provided or no applicable.There was no medical intervention was required.

Manufacturer Narrative

The device was returned for evaluation; however, testing has not yet been completed.

Manufacturer Narrative

The used d1000 tego connector was visually inspected for occlusion that would result in resistance to flow during use.The fluid path was completely open without evidence of occlusion.A subsequent fluid test showed the fluid flowed without restriction.Finally the used d1000 tego connector was pressure and vacuum leak tested without failure.The complaint was unable to be replicated or confirmed.

• Brand Name: TEGO¿ CONNECTOR
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.; avenida cuarzo no. 250; ensenada, b.cfa. 22790 ; MX 22790
• Manufacturer Contact: reed covert ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 18190762
• MDR Text Key: 328783424
• Report Number: 9617594-2023-01018
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K053106
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/21/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: D1000
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/21/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/24/2023
• Initial Date FDA Received: 11/22/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1